BASAGLAR Drug Profile

Summary for Tradename: BASAGLAR

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for BASAGLAR
Recent Clinical Trials:	See clinical trials for BASAGLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BASAGLAR

See drug prices for BASAGLAR

Recent Clinical Trials for BASAGLAR

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Eli Lilly and Company	Phase 3
Eli Lilly and Company	Phase 4
LMC Diabetes & Endocrinology Ltd.	Phase 4

See all BASAGLAR clinical trials

Recent Litigation for BASAGLAR

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all BASAGLAR litigation

Pharmacology for BASAGLAR

Established Pharmacologic Class	Insulin Analog
Chemical Structure	Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for BASAGLAR Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BASAGLAR Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for BASAGLAR Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,004,686	2025-05-23	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,016,338	2033-03-11	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,029,011	2029-11-13	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,092,513	2033-04-03	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,117,909	2028-10-17	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,118,956	2034-12-01	Patent claims search
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	10,155,799	2034-07-21	Patent claims search

BASAGLAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Basaglar

Introduction

Basaglar, a biosimilar of the insulin glargine injection Lantus, has been a significant player in the diabetes treatment market since its approval. Here, we will delve into the market dynamics and financial trajectory of Basaglar, highlighting its impact on the pharmaceutical industry and patient care.

Approval and Market Entry

Basaglar, developed by Eli Lilly and Boehringer Ingelheim, was approved by the FDA in December 2015 but faced delays due to patent litigation with Sanofi, the manufacturer of Lantus. It finally entered the U.S. market in December 2016[2].

Market Impact on Pricing

The introduction of Basaglar led to a significant downward trend in the pricing of Lantus. A study published in JAMA Internal Medicine found that after Basaglar's approval, the net prices of Lantus decreased on average by $0.67 per quarter relative to the preapproval trend. This shift indicates that the presence of a biosimilar can drive down the prices of the reference biologic, benefiting patients and healthcare systems[2].

Revenue Performance

In the full year of 2021, Basaglar generated worldwide revenue of $892.5 million, which represented a 21% decrease compared to the full year of 2020. This decline could be attributed to various market factors, including increased competition and pricing pressures[1].

Quarterly Revenue

For the third quarter of 2021, Basaglar's worldwide revenue was $192.8 million, a decrease of 22% compared to the same period in 2020. This quarterly performance reflects the ongoing challenges in maintaining revenue growth in a competitive market[5].

Market Share

By 2020, Basaglar accounted for 39% to 41% of all net sales of insulin glargine products in the U.S., while Lantus maintained the highest net sales with 45% to 46% market share. This indicates that Basaglar has successfully carved out a significant portion of the market, despite the dominance of the original biologic[2].

Financial Performance of Eli Lilly

The financial performance of Eli Lilly, the company behind Basaglar, provides additional context. In 2021, Eli Lilly reported total revenue of $28,318.4 million, a 15% increase from 2020. However, the revenue from Basaglar itself was on the decline, reflecting broader market dynamics and competition[1].

Non-GAAP Financial Measures

On a non-GAAP basis, Eli Lilly's net income and EPS for 2021 showed a 20% increase compared to 2020, driven by higher operating income and favorable product mix. This suggests that while Basaglar's revenue may be declining, the overall financial health of Eli Lilly remains robust[1].

Cost Savings and Patient Impact

The introduction of Basaglar has contributed to significant cost savings in the biologic market. According to the Association for Accessible Medicines, biosimilars like Basaglar were responsible for driving savings of $7 billion in biologic spending in 2021 alone, with cumulative savings since 2015 reaching $13 billion[4].

Patient Access and Affordability

Despite these savings, challenges remain in ensuring patient access to affordable insulin. Nearly 20% of Americans still resort to insulin rationing due to cost constraints. The transition to biosimilars like Basaglar, while beneficial, highlights the complexities within U.S. pharmaceutical channels and the need for continued efforts to improve affordability[4].

Future Outlook and Regulatory Environment

Looking ahead, biologics that have been on the market for at least 13 years will be subject to negotiation starting in 2026 for Medicare, which could further impact pricing and market dynamics. The growth of the biosimilars market, including the pursuit of interchangeability designations, is expected to continue, with many manufacturers viewing interchangeability as a competitive advantage[4].

Competitive Landscape

The biosimilars market is becoming increasingly competitive, with several classes experiencing high single-digit or even double-digit adoption growth. Basaglar, as one of the pioneers in the insulin glargine biosimilar space, faces competition from other biosimilars and generic products, which can affect its market share and revenue[4].

Conclusion

Basaglar's entry into the market has significantly impacted the pricing and accessibility of insulin glargine, contributing to cost savings and improved patient care. However, its revenue has faced challenges due to market competition and pricing pressures. As the biosimilars market continues to evolve, Basaglar remains a key player, but its future success will depend on navigating the complex regulatory and competitive landscape.

Key Takeaways

• Basaglar's approval led to a downward trend in Lantus pricing.
• Basaglar generated $892.5 million in revenue in 2021, a 21% decrease from 2020.
• By 2020, Basaglar accounted for 39% to 41% of insulin glargine net sales in the U.S.
• Biosimilars like Basaglar have driven significant cost savings in biologic spending.
• Patient access to affordable insulin remains a challenge despite cost savings.
• Future regulatory changes and competitive dynamics will shape Basaglar's market position.

FAQs

Q: What is Basaglar and when was it approved?

A: Basaglar is a biosimilar of the insulin glargine injection Lantus. It was approved by the FDA in December 2015 but entered the U.S. market in December 2016 due to patent litigation.

Q: How has Basaglar affected the pricing of Lantus?

A: The approval of Basaglar led to a significant downward trend in the pricing of Lantus, with net prices decreasing on average by $0.67 per quarter relative to the preapproval trend.

Q: What was the revenue performance of Basaglar in 2021?

A: In 2021, Basaglar generated worldwide revenue of $892.5 million, which was a 21% decrease compared to the full year of 2020.

Q: What market share does Basaglar hold in the U.S. insulin glargine market?

A: By 2020, Basaglar accounted for 39% to 41% of all net sales of insulin glargine products in the U.S.

Q: How have biosimilars like Basaglar impacted healthcare costs?

A: Biosimilars like Basaglar have driven significant cost savings in biologic spending, with cumulative savings since 2015 reaching $13 billion.

Sources

1. Lilly Reports Solid Fourth-Quarter and Full-Year 2021 Financial Results - Investor Lilly
2. Biosimilar Insulin Glargine Led to Downward Trend in Pricing - Managed Healthcare Executive
3. Lilly Reports Fourth-Quarter 2022 Financial Results, Core Business - Investor Lilly
4. 2023 Biosimilars Report - Cardinal Health
5. Lilly Reports Robust Third-Quarter 2021 Financial Results as Pipeline Success Strengthens Future Growth Potential - BioSpace